The World Health Organization on Monday announced the outcome of its ethical deliberations. It found that, in certain circumstances, it was ethically permissible to use unproven drugs on Ebola patients.
It then listed ethical criteria. These included transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community.
These are laudable principles but what do they actually mean in practice? The devil is in the detail. If you broke your ankle after slipping on coffee in a hotel, and asked a lawyer if you would win a case against the hotel, you would be frustrated if the lawyer simply recited a legal principle: “the hotel owes you a duty to take reasonable care to see that you are reasonably safe in using the premises”. You want to know whether, in your case, the hotel did take reasonable care. To resolve your problem, the legal principle must be applied to the facts.
Summary: Patients potentially infected with Ebola have the right to experimental treatment outside of randomised controlled trials. Consent should be sought while they are competent if it is anticipated that they will lose competency through the disease. In the most extreme emergencies, experimental treatment could be given without consent in the public interest. However, in such extreme emergencies, such if the virus were to mutate to become very highly transmissible, selection of patients for such trials should be on a principle of justice. This would generally require selecting patients with the worst prognosis as initial subjects. Whilst the current outbreak has been declared an international health emergency, it does not warrant over-riding standard ethical principles of consent and autonomy.
WHO are convening a meeting next week to discuss the use of untested treatments for the current Ebola outbreak, which it has declared to be an international public health emergency.
Dr Marie-Paule Kieny, Assistant Director-General at the World Health Organization explained “We are in an unusual situation in this outbreak. We have a disease with a high fatality rate without any proven treatment or vaccine,”
With a fatality rate of recent outbreaks at around 50%, and current treatments consisting of little more than rehydration, it is easy to see why this experimental approach is an attractive option. Jeremy Farrar, David Heymann and Peter Piot argued convincingly in favour of such measures.
However, there are a number of diseases which meet Dr. Kieny’s criteria of “a high fatality rate without any proven treatment or vaccine”. While Kieny is referring to infectious disease, sufferers of other diseases have campaigned for many years for access to untested medicines. Along with several colleagues, I wrote a paper on this subject with Les Halpin, who recently died from motor neurone disease, having campaigned for access to medicines for many years
The case for
I have argued that, when a patient is facing a certain death from an incurable disease, the relative safety that randomised controlled trials provide is unnecessary- especially when the payoff is a placebo group of patients who receive no benefit at all.
One common reason in support of randomised controlled trials is safety. This is true for most patients: patients for whom there are other good treatment options, or whose disease is not itself life-threatening. But for some patients, this concern is a cruel irony. Their disease is so overwhelmingly unsafe that any risk is outweighed by potential benefits. Udo Schuklenk reports Martin Delaney, a trial patient for AIDS who described the situation vividly:
It is as if I am in a disabled airplane, speeding downward out of control. I see a parachute hanging on the cabin wall, one small moment of hope. I try to strap it on, when a would be government employee reaches out and tears it off my back, admonishing, ‘You cannot use that! It does not have a Federal Aviation Administration sticker on it. We do not know if it will work’
In 2005, the NZ Herald reported. “A man with motor neurone disease plans to starve himself to death rather than wait to die.
“Thirty-nine-year-old Andrew Morris of Hamilton has limited movement and can barely speak. He has gone public with his decision because he wants law changes to allow voluntary euthanasia.”
Such cases occur not infrequently, around the world. Last month, John Rehm took his life by dehydration. NBC News reported:
Diane Rehm and her husband John had been married for 54 years when he knew he didn’t want to live another day.
His Parkinson’s disease had become unbearable. “He just kept getting weaker,” the NPR host told NBC News. “We called in the doctor and John said to him: ‘I am ready today.’ He said ‘I can no longer use my legs, I can no longer use my arms, I can no longer feed myself.’ And knowing with Parkinson’s it is going to get worse rather than better, he said ‘I wanted to die.’” He asked the doctor for help.
The answer they got surprised and disappointed both of them. “The doctor said ‘I cannot do that legally, morally or ethically’,” Rehm said. “He said ‘I don’t disagree with your wish that you could die with the help of a physician but I cannot do it in the state of Maryland.’”
John Rehm had to deliberately die by dehydration. It took nine days.
“John said he felt betrayed,” Rehm said. He said, ‘I felt that when the time came, you would be able to help me.’”
In a recent, short commentary on the sad case of Tony Nicklinson, I argued that two basic moral rights effectively equate to a legal right to slow assisted dying. In one sense, Rhem’s doctor was wrong.
Firstly, everyone, including Mr Hamilton, has a basic right to control what goes into their bodies, including food and fluids. Everyone has a basic right to refuse to eat and drink, even if this results in their death.
Secondly, everyone has a basic right to health care, including the relief of pain and suffering. As someone is dying, they have a right to palliative care to achieve that end. This includes the administration of narcotics and sedatives, as necessary to relieve their suffering and as requested by the patient. This is so, regardless of whether their suffering is self-inflicted or not.
by Dominic Wilkinson (@NeonatalEthics)
Lord Falconer’s assisted dying bill is being debated today in the House of Lords. In the past week or two there has discussion in the media of many of the familiar arguments for and against such a proposal. As Roger Crisp noted in yesterday’s post, there have been relatively few new arguments. Supporters of the bill refer to compassion for the terminally ill, the difficulty of adequately relieving suffering, and patients’ right to make fundamental choices about the last stage of their lives. Opponents of the bill express their compassion for the terminally ill and those with disabilities, fear about coercion, and the omnipresent slippery slope.
One concern that has been raised about the assisted dying bill is the fear of abuse in the setting of an overstretched public health system. For example, Penny Pepper, writing in the Guardian notes that “Cuts to social care are monstrous…How would the enactment of the Falconer bill work if brought to our harassed NHS?”
Tomorrow in the House of Lords Lord Falconer’s bill on assisted dying will be debated. The bill would allow those who are terminally ill and likely to die within six months to request life-ending drugs from their doctor for the patients to use as and when they see fit.
As might have been expected, there has been huge discussion over the bill, but most of the arguments presented so far are not new, and the same will probably be true tomorrow. But there is one I haven’t seen before, put forward recently by Giles Fraser: that assisted suicide is the ‘final triumph of market capitalism’. Continue reading
It is a curious feature of the late 20th and early 21st centuries that the media regales readers and viewers almost daily with exciting details of breakthroughs in medical science: new cures, reversals of previous certainties about old remedies (and then, often enough, later reversals of the reversals), astonishing information about our brains and numerous other organs, apparently dramatic discoveries about free will and ethical thinking. Much of this is indeed attributable to the rapid rate of the expansion of contemporary scientific understanding which we should not want to underestimate, but it is also sometimes the result of the media’s excitability and search for sensation, combined with the impressive self-promotional skills of practitioners of the medical sciences. This latter factor means that reported “breakthroughs” are often no more than confident early steps on a promising but uncertain path, and when they lead nowhere this sad news tends not to see the light of day. And then there are the cases of outright fraud or incompetence, such as the South Korean scientist Hwang Woo-suk’s initially much-proclaimed breakthroughs in the early 2000s in stem cell research that were shown to be faked.
So a certain reserve about reported breakthroughs is in order, but a recent case is worth philosophical scrutiny even if its claims turn out to be less valid than they seem. This was a report in The Mail Online, Science and Technology section that was headlined “Could Pill wipe out bad memories? Drug used to treat multiple sclerosis found to help us forget experiences that caused us pain.” But it turns out that the drug has only been tested for memory erasure of pain in mice, and then only of a specific type of pain associated with mild electric shock. The Mail article jumps rapidly from this modest beginning to claim that the experiment “offers hope of a drug that could eradicate memories of traumatic events from years ago and help patients overcome phobias, eating disorders and even sexual hang-ups.” For none of this “hope” is there an iota of evidence in the scientific study and one of the scientists involved in the study at the Commonwealth University of Virginia, Dr Sarah Spiegel, showing appropriate modesty, said of the drug concerned: ‘Fingolimod, a Food and Drug Administration approved drug for treatment of multiple sclerosis, has beneficial effects in the central nervous system that are not yet well understood.” More ambitiously she added: “Fingolimod deserves consideration as an adjuvant therapy for post traumatic stress disorder and other anxiety disorders.”
Last month Quebec legalised assisted-death. The new law allows ‘medical aid in dying’ for adults at the end of life who suffer “constant and unbearable physical or psychological pain” as a result of a “serious and incurable illness”. The passage of this law makes Quebec the first jurisdiction in Canada to allow assisted-death or euthanasia.
The Bill follows successful legalisation of assisted-dying just south of Quebec last year in the American state of Vermont. Jurisdictions in which the practice is now legal include the Netherlands, Switzerland, Belgium, Luxembourg, Washington, Montana and Oregon.
Surprisingly, the arguments for and against assisted-death and euthanasia haven’t been discussed all that frequently on this blog. So this post will consider: would legalising assisted-death (patient administered) or voluntary euthanasia (physician administered) provide a compassionate exit to those facing decline and suffering and the means to live and die by our own lights, or involve a repugnant devaluation of human life that would put the vulnerable at risk?
By Kimberly Schelle & Nadira Faulmüller
Horizon 2020, the European Union’s 2014-2020 largest research programme ever, includes the call to pursue ‘Responsible Research and Innovation’ (RRI). RRI stands for a research and innovation process in which all societal actors (e.g. citizens, policy makers, business and researchers) are working together in the process to align the outcomes with the values, needs, and expectations of the European Society. In a recently published paper on the importance of including the public and patients’ voices in bioethical reasoning, the authors describe, although in other words, the value of the RRI approach in bioethical issues:
“A bioethical position that fails to do this [exchange with the public opinion], and which thus avoids the confrontation with different public arguments, including ones perhaps based in different cultural histories, relations and ontological grounds […], not only runs the risk of missing important aspects, ideas and arguments. It also arouses strong suspicion of being indeed one-sided, biased or ideological—thus illegitimate.”
The Court of Appeal has stated that a statement in a capacitous patient’s medical notes that resuscitation should not be attempted (a ‘Do Not Attempt Resuscitation’ Order – DNAR), should usually only be inserted after consultation with the patient: see R (Tracey) v Cambridge University Hospitals NHS Foundation Trust and others  EWCA Civ 822 (17 June 2014).
The facts have been widely aired in the media: see, for example, here.
Mrs. Tracey had terminal lung cancer. Her clinicians indicated in the notes that no attempts at resuscitation should be made. Her family found out about this, and were outraged, saying that the DNAR order should not have been made without consultation with Mrs. Tracey. Their quarrel was not with the medical appropriateness of the determination that resuscitation would not be in Mrs. Tracey’s best interests, but with the procedure - the failure to consult. This, they said, violated Mrs. Tracey’s rights under Article 8 of the ECHR.
The Resuscitation Council, intervening, said that a requirement to consult with the patient would interfere with clinicians’ ability to deliver individual and compassionate care. A patient might, for instance, be very distressed by a discussion about a possible DNAR order.
The outcome can be briefly stated:
- Mrs. Tracey’s Article 8 rights were engaged by recording the DNAR in the notes. This followed from, inter alia, Pretty v UK (2002) 35 EHRR 1.
- Her Article 8(1) rights were violated by failing to involve her in the process
- Article 8(2) required the policy adopted by a Trust in relation to DNAR orders to be sufficiently clear and accessible: see Purdy v DPP  UKHL 45;  1 AC 345.
- The absence of a mandatory national DNAR policy was not a violation of Article 8. Local policies would, if properly formulated, satisfy the demands of Article 8(2)
- The concerns of the Resuscitation Council were real, but could be met by an important caveat: there should be consultation with the patient unless the clinician ‘thinks that the patient will be distressed by being consulted and that distress might cause the patient harm.’ Continue reading